Letter from the CEO

Investors
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Letter from the CEOPhase 3 preparations and broader pipeline developments progressIn the first quarter of 2025, Mendus provided a summary of the supportive feedback from EMA and FDA related to the preparations for a registration trial with our lead product vididencel in AML.
The feedback was based on our questions related to registration trial design and other considerations, including steps required for the transition to large-scale production. The objective of our manufacturing alliance with NorthX Biologics is to accomplish large-scale GMP production of vididencel in the second half of 2025, representing a major milestone for late-stage clinical development.



 

Erik Manting, CEO
Parallel to the ongoing Phase 3 preparations, we are expanding the clinical development of vididencel and in February we announced that the first patient was enrolled in the AMLM22-CADENCE trial, a randomized-controlled combination trial with oral azacitidine supported by the Australasian Leukaemia and Lymphoma Group (ALLG). We are also preparing additional clinical trials to explore the broader positioning of vididencel in AML and other blood-borne tumors.
For our solid tumor program in ovarian cancer, we presented, together with our academic collaborators at the University Medical Centre Groningen (UMCG), for the first time the use of the platform to expand tumor-infiltrating lymphocytes (TILs) from ovarian cancer tissue samples at the Immunotherapy of Cancer (ITOC) conference held early April. The observed strong expansion of functional TILs could lead to improved production of TILs for the treatment of ovarian cancer and other solid tumors. Together with UMCG, we will also present data from the ongoing ALISON ovarian cancer trial at the upcoming American Society of Clinical Oncology meeting (ASCO) in May.
As our Phase 3 preparations and broader pipeline developments progress, we look forward to keeping our stakeholders informed and thank you for your continued interest in Mendus.
Erik Manting, Ph.D.

Chief Executive Officer
 
*Published on May 6, 2025